Shanghai, China | full time | Job ID: 11516 Your contribution: Represent External QC Network at CMOs (predominantly located in China) ensuring QC and GMP requirements of BioNTech are considered Represent external/global QC in multidisciplinary project team and define
We are looking for the right people — people who want to innovate, achieve, grow and lead. We attract and retain the best talent by investing in our employees and empowering them to develop themselves and
Job Overview: Site monitoring and site management responsibility for clinical studies according to Company, and/or Sponsor, Standard Operating Procedures, and Regulatory Guidelines. Assures the implementation of project plans, as assigned. Summary of Responsibilities: Responsible for all
About Human Pharmaceutical Business With global presence, Boehringer Ingelheim has industry-leading expertise in medicine research and development. We are constantly developing the next generation of medical breakthroughs and successfully delivering innovations to meet the medical needs
When our values align, theres no limit to what we can achieve. At Parexel, we all share the same goal - to improve the worlds health. From clinical trials to regulatory, consulting, and market access, every
Job Description 岗位概述: 负责兽用疫苗产品在生产过程和放行前的质量检验与实验室管理,确保检验结果准确、合规并符合公司及监管机构的质量标准。作为QC团队的核心执行者,需协同生产、研发等部门,推动检验方法的优化与实验室持续改进。 主要职责: 协助QC经理建立和完善质量控制制度、检测流程,推动质量体系持续改进; 主导中国兽药典检测方法、兽药GMP等法规要求的落地执行; 监督并参与病毒含量、外源病毒、细胞库建立、菌毒种扩繁等工作; 协助QC经理审核检测记录、分析报告、分析方法验证、设备验证等放行文件; 分析检验趋势数据,提出质量改进建议,参与实验室流程优化与成本控制项目; 组织和跟进偏差、CAPA(纠正与预防措施)、变更控制,推动根本原因分析并实施改进措施; 配合GMP等监管检查与客户审计,准备审计资料并组织回复; 与研发、生产及公司其他工厂保持沟通,参与方法验证、方法转移、稳定性试验及质量问题解决。 任职要求: 学历专业:本科及以上学历,微生物学、生物制药、药学、兽医、生物技术等相关专业。 工作经验:5年以上动物生物疫苗行业QC工作经验,具备生物疫苗批检验、稳定性研究及方法学验证经验者优先。 专业能力:熟悉中国兽药典检测方法、兽药GMP等相关法规与标准;熟悉细胞培养、病毒培养等生物学方法及质控技术,能独立解决复杂的质量问题。 核心素养:具备较强的问题解决能力、数据分析能力和项目推进能力,能独立开展组织协调与跨部门沟通能力;数据敏感度高,逻辑严谨,责任心强,能承受一定工作压力;英语流利者优先。 Required Skills: Adaptability, Analytical Instrumentation, Analytical Method Development, Decision Making, Detail-Oriented, Forensic Chemistry, Good Manufacturing Practices (GMP), Laboratory Information Management System (LIMS),
The Bioanalysis Laboratory supports AstraZeneca R&D China by generating quality-compliant PK, PD, ADA, NAb, and biomarker data for cell therapy projects, biotherapeutic development and regulatory filing. The Associate Principal or Principal Bioanalysis Scientist is responsible for: Leading
When our values align, theres no limit to what we can achieve. At Parexel, we all share the same goal - to improve the worlds health. From clinical trials to regulatory, consulting, and market access, every
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When our values align, theres no limit to what we can achieve. At Parexel, we all share the same goal - to improve the worlds health. From clinical trials to regulatory, consulting, and market access, every
Serve as SDTL Responsible for planning and leading the delivery of all components of a clinical study to time, cost, and quality from Study Specifications (SS) through study closeout activities and Clinical Study Report (CSR). Form
Serve as SDTL Responsible for planning and leading the delivery of all components of a clinical study to time, cost, and quality from Study Specifications (SS) through study closeout activities and Clinical Study Report (CSR). Form
When our values align, theres no limit to what we can achieve. At Parexel, we all share the same goal - to improve the worlds health. From clinical trials to regulatory, consulting, and market access, every
When our values align, theres no limit to what we can achieve. At Parexel, we all share the same goal - to improve the worlds health. From clinical trials to regulatory, consulting, and market access, every
Job Overview 综述 Quality specialist Responsibilities 职责 Demonstrate support for the vision of excellence in EHS and implement corresponding roles and responsibilities specified in “Celanese Employees and Leaders EHS Roles and Responsibilities” matrix Develop test method
Why Patients Need You Pfizer Worldwide Medical and Safety colleagues play a key role in connecting evidenced based, medical decision support with colleagues and stakeholders to enable better health and treatment outcomes. Whether you are creating
When our values align, theres no limit to what we can achieve. At Parexel, we all share the same goal - to improve the worlds health. From clinical trials to regulatory, consulting, and market access, every
The Opportunity: Executes day-to-day lab operations & support objectives at customer facilities, following a varied set of procedures, focused on minimizing laboratory workflow interruptions. Problems and issues are typically less concrete and frequently changing, and are
Work ScheduleStandard (Mon-Fri) Environmental ConditionsOffice Job Description Join Us as a Senior Clinical Research Associate (Level I) – Make an Impact at the Forefront of Innovation We have successfully supported the top 50 pharmaceutical companies and more
The Opportunity: Workers engaged for short-term needs or specific projects Technician Scientific Support, Onsite Job Objectives: Follow up on production projects, deliver on time, ensure the smooth progress of production projects, and complete method development, transfer,